Cancer in the Elderly: Prevalence and Impact of Age Related Problems

April 17, 2018 updated by: Sykehuset Innlandet HF

Cancer in the Elderly: Prevalence and Impact of Age Related Problems. A Prospective Observational Study

About 50% of cancer patients are >70 years at diagnosis. Age related somatic and psychiatric problems may influence the course of cancer and its treatment. The present study is a prospective observational study. Age related problems will be assessed by clinical frailty indicators covering areas that are recommended in geriatric oncology. The aim is to describe the frequency of age related problems in a cohort of Norwegian cancer patients > 70 years of age, to investigate the predictive/prognostic impact of these indicators on cancer and treatment related morbidity and mortality, and to investigate the association between clinical frailty indicators, sarcopenia (severe loss of muscle mass) and inflammatory response. Patients are recruited at outpatient cancer services, Innlandet Hospital HF (SI), Oslo University Hospital, and Akershus University Hospital. Estimated sample size is 300 with 30 months inclusion and 2 years follow-up. The study emerges from SI in collaboration with several external national and international centres

Study Overview

Status

Completed

Conditions

Detailed Description

The proportion of elderly cancer patients is high and is likely to increase due to an increasing cancer incidence and an aging population. The prevalence and impact of age related problems are, however, poorly documented, and elderly patients may therefore be subjects to under-treatment and arbitrary modifications of treatment regimens. In order to improve clinical practice, precise identification of patients with increased vulnerability and risk of adverse outcomes is paramount.

In the present study, eligible patients will be identified by referral to oncology services at one of the participating cancer units. After consent, the baseline registrations will be performed including relevant medical and sociodemographic data, and quality of life. Age related problems will be assessed by clinical indicators covering comorbidity, medication, emotional, physical and cognitive function and nutritional status. Muscle mass will be quantified by analyses of diagnostic CT scans and a biobank will be established for the analyses of inflammatory markers. Upon inclusion, the patients' physician will be asked to rate the patients as fit, frail or intermediate according to the physicians' subjective judgement. The patients will be followed with assessments of quality of life, emotional function and nutritional status (self-report), cognitive and physical function (self-report and performance tests), muscle mass (diagnostic CT scans when available) and inflammatory markers (biobank). Follow up data will also include registry data (hospital records, primary health care registries, The Norwegian Patient Registry, The Norwegian Cancer Registry and the Norwegian Cause of Death registry). We will describe the prevalence of age related problems, investigate the relation between clinical frailty indicators, sarcopenia, inflammatory response and the physicians' subjective evaluation of the patients' health status. The predictive/prognostic impact of frailty indicators on the patients' self-reported physical function and quality of life, hospital and nursing home admittance, treatment toxicity and survival will also be investigated

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Brumunddal, Norway
        • Innlandet Hospital Trust
      • Oslo, Norway, 0424
        • Oslo University Hospital Ullevål
    • Lørenskog
      • Lillestrøm, Lørenskog, Norway, N-1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consequetive patients referred to a specialist outpatient clinic for medical cancer treatment

Description

Inclusion Criteria:

  • age >= 70 years
  • histologically/cytologically verified cancer disease
  • referred to specialist oncology service
  • no former chemotherapy for actual status (new cancer diagnosis no former or chemotherapy for metastatic disease)
  • subject to medical oncological treatment that may be initiated and administered at the hospital trust the patient is referred to
  • able to provide written consent
  • fluent in Norwegian (orally and written)

Exclusion Criteria:

- lymphomas and haematological malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Older cancer patients
Older cancer patients 70 years or older referred to specialist oncology outpatient clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of age related problems
Time Frame: At baseline
Age related problems assessed by clinical indicators including comorbidity, medication, emotional, physical, cognitive function, nutritional status and quality of life
At baseline
Physical decline
Time Frame: Follow-up
Physical decline during follow-up, as measured by the EORTC QLQ-C30 questionnaire. We will investigate the predictive value of frailty (measured by clinical indicators), sarcopenia and inflammatory response on this outcome. Primary endpoint is defined as 2 months of follow-up
Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital and nursing home admittance
Time Frame: 2-4 months and 2 years follow-up
The predictive value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome
2-4 months and 2 years follow-up
Quality of life
Time Frame: 2 - 4 months and 2 years follow-up
The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome
2 - 4 months and 2 years follow-up
Treatment toxicity
Time Frame: 2-4months and up to 2 years
The predictive impact of frailty indicators (including clinical indicators, sarcopenia and inflammatory response) on the outcome "treatment toxicity" defined in terms of any adverse event requiring hospital admission and haematological toxicity (grade 3-4 cytopenia). Toxicity during the first course of chemotherapy (2-3 weeks), during 3-4 courses (2-3 months) and for the whole follow-up. i.e. up to 2 years will be investigated
2-4months and up to 2 years
survival
Time Frame: 2 years follow-up
The prognostic value of frailty indicators (including clinical indicators, sarcopenia and inflammatory response on the outcome
2 years follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between clinical frailty indicators, sarcopenia and inflammatory response
Time Frame: Baseline and 2 years follow-up
Association between clinical frailty indicators, sarcopenia and inflammatory response
Baseline and 2 years follow-up
The association between physicians' subjective evaluation of the patients' health status and clinical frailty indicators
Time Frame: Baseline and 2 years follow-up
Agreement between physicians evaluation of health status and frailty based on a systematic assessment of frailty indicators
Baseline and 2 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Collaborators

Vestre Viken Hospital Trust
Oslo University Hospital
University of Alberta
Diakonhjemmet Hospital

Investigators

  • Principal Investigator: Marit S Jordhøy, MD, PhD, Sykehuset Innlandet and Oslo University Hospital
  • Principal Investigator: Siri Kristjansson, MD, PhD, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (ESTIMATE)

December 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E12224
  • 2012/104 C (OTHER: Regional Ethical Review Board HSO, Norway)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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